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Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of neuropathy in patients receiving paclitaxel.
- Source :
-
Trials [Trials] 2023 Feb 03; Vol. 24 (1), pp. 79. Date of Electronic Publication: 2023 Feb 03. - Publication Year :
- 2023
-
Abstract
- Background: Peripheral neuropathy is a common dose-limiting side effect of paclitaxel. To date, there is no effective strategy to prevent paclitaxel-induced peripheral neuropathy. A recent small phase II study demonstrated the potential role of oral gabapentin in this setting. This phase III study is aimed to assess the efficacy of oral gabapentin in preventing paclitaxel-induced neuropathy.<br />Objective: To compare the efficacy of oral gabapentin with placebo in preventing clinically significant peripheral neuropathy (NCI CTCAEv5.0 grade 2 or higher) in patients receiving paclitaxel.<br />Methods: This is a randomized, placebo-controlled, double-blind, parallel-group superiority trial. The primary outcome is the development of grade 2 or higher chemotherapy-induced peripheral neuropathy. Secondary outcomes include any grade neuropathy, the percentage change in sensory nerve conduction velocities in peripheral nerves, time to development of any grade neuropathy, paclitaxel dose reductions and delays due to peripheral neuropathy, patient-reported outcomes, adverse events, and adherence to oral therapy. A total of 136 patients receiving paclitaxel will be randomly allocated (stratified by weekly vs. non-weekly administration) to receive either oral gabapentin or placebo till three weeks after the last dose of chemotherapy or occurrence of the primary outcome.<br />Conclusion: This study aims to find if oral gabapentin reduces the incidence of grade 2 or higher chemotherapy-induced peripheral neuropathy in patients receiving paclitaxel.<br />Trial Registration: The trial is registered prospectively with the Clinical Trials Registry of India (CTRI/2022/02/040030) on April 4, 2022.<br /> (© 2023. The Author(s).)
- Subjects :
- Humans
Paclitaxel adverse effects
Gabapentin adverse effects
India
Double-Blind Method
Antineoplastic Combined Chemotherapy Protocols adverse effects
Peripheral Nervous System Diseases chemically induced
Peripheral Nervous System Diseases diagnosis
Peripheral Nervous System Diseases prevention & control
Antineoplastic Agents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 36732774
- Full Text :
- https://doi.org/10.1186/s13063-023-07126-1